Pathways' Pick of the Week: Post-MCIT Positioning

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CMS will convene two stakeholder meetings in 2022 to talk about policymaking for Medicare coverage of innovative devices. Excerpted from Pathways' Picks November 17: Big Week in Washington, Aussie Reclassifications, China Picks, and More.

CMS says it will convene two stakeholder meetings next year to talk about policymaking for Medicare coverage of innovative devices. On November 12, the agency followed-through on its plan to repeal the Medicare Coverage of Innovative Technology (MCIT) program that would have granted automatic, no-strings-attached four years of national coverage to many FDA-designated Breakthrough Devices starting on the day of approval.

Any future policies that come out of CMS will hew much more closely to existing pathways, including the national and local coverage determination (NCD and LCD) processes, the final repeal rule makes clear. CMS said that it is working with its sister agency, the Agency for Healthcare Research and Quality (AHRQ) to refine study criteria associated with the coverage with evidence development (CED) program, under which CMS grants coverage on the condition that specific data continues to be collected either in a registry or clinical trial. CMS is also discussing with AHRQ other options to expedite the NCD process. It seems evident that any future policies will not be targeted specifically at FDA Breakthrough Devices—based on concerns of unfair advantages for certain products—and will include more assurances of Medicare beneficiary evidence pre- and post-coverage.

Nonetheless, CMS emphasized that it “does not intend to maintain the status quo. We remain committed to our goal of establishing an alternative expedited coverage pathway that better achieves the goals of timely and predictable Medicare coverage of devices while ensuring that Medicare covers items and services on the basis of scientifically sound clinical evidence and with appropriate safeguards.” 

Device groups say they are disappointed by the repeal but ready to work with CMS on alternatives. Nonetheless, more attention is now likely to shift to Congress, where provisions to enact an enhanced version of the original MCIT program were officially introduced this week (see next brief) and could potentially tack on to “must pass” FDA user fee legislation next year.

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